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510(k) Data Aggregation
(105 days)
The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants Ø3.3mm Narrow Neck for use up to six months.
The Straumann Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The device covered in this submission is a temporary coping. The Straumann Narrow Neck Temporary Coping intended to serve as a base for temporary restorations. The temporary coping is for use on the Straumann Standard Plus Ø3.3mm Narrow Neck Implant.
This 510(k) submission (K070744) is for a Narrow Neck Temporary Coping, which is an accessory to an endosseous dental implant. The submission primarily focuses on establishing substantial equivalence to existing legally marketed predicate devices rather than demonstrating performance against specific acceptance criteria through a standalone study.
Therefore, many of the requested elements regarding acceptance criteria and performance studies are not explicitly present in the provided text because the device is a simple mechanical component and its safety and effectiveness are established by comparison to similar devices already on the market. The FDA clearance is based on the device being substantially equivalent in intended use, operating principle, basic design, and materials.
Here's an analysis based on the provided text, indicating what information is available and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as part of a performance study for this device type. The basis for substantial equivalence is listed. | The device is deemed "substantially equivalent" to predicate devices K032498 and K051717 in intended use, operating principle, basic design, and materials. No specific performance metrics (e.g., tensile strength, fatigue life) or quantitative results are provided in this summary, as is typical for substantial equivalence claims for mechanical accessories. |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This submission does not describe a performance study with a test set of data as it relies on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. No such expert review or ground truth establishment is described for a performance study in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. There is no test set or adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-powered device, nor is it a diagnostic imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. The "ground truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not a machine learning/AI device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As above, no training set exists.
Summary of the Study (Basis for Substantial Equivalence):
The "study" or basis for acceptance in this 510(k) is a substantial equivalence comparison to two legally marketed predicate devices:
The document explicitly states: "The proposed device is substantially equivalent in intended use, operating principle and basic design and is made of the same materials as the currently marketed devices." This implies that the safety and effectiveness of the proposed Narrow Neck Temporary Coping are demonstrated by its similarity to already cleared devices, rather than through independent prospective or retrospective performance studies with clinical data.
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